NCT01984398

Comparison of Two Formulations of Androxal

A Double-Blind Crossover Study In Healthy Volunteers to Compare Two Formulations of Androxal

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

Detailed description

To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	12.5 mg Androxal Formulation A	Single dose of 12.5 mg Androxal formulation A
DRUG	12.5 mg Androxal Formulation B	Single dose of 12.5 mg Androxal Formulation B
DRUG	25 mg Androxal Formulation A	Single dose of 25 mg Androxal formulation A
DRUG	25 mg Androxal Formulation B	Single dose of 25 mg Androxal formulation B

Timeline

• Start date: 2013-12-31
• Primary completion: 2013-12-31
• Completion: 2013-12-31
• First posted: 2013-11-14
• Last updated: 2019-05-06
• Results posted: 2019-05-06

Locations

1 site across 1 country: United States